Senior Clinical Trial Coordinator

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeClinical Tempo inteiro R$96.200 - R$128.450
Clinical Site Navigator Role Overview

The Clinical Site Navigator role combines start-up and iHCRA/CRA responsibilities, playing a critical part in coordinating site-level activities throughout the start-up phase of a clinical trial.

  • Activating sites efficiently while ensuring compliance with ICH/GCP guidelines, local regulations, SOPs, and project requirements is key to this role.
  • Potential research sites are identified, assessed for capabilities, and initially contacted, including feasibility surveys and confidentiality agreements.
  • Supporting documentation for site selection includes remote pre-study visits, visit preparation, and follow-up documentation.
  • Managing essential documents for site activation, maintaining regulatory compliance, and supporting renewals and amendments is crucial.
  • Participating in team meetings, addressing site risks or issues, and supporting the CRA team in preparing for SIVs is also an important aspect.
  • Submissions to IRB/IEC and regulatory authorities are supported in collaboration with the Regulatory Submissions Lead.
  • Negotiating initial contracts and budgets with sites is also required.
  • Accurate documentation and system compliance are ensured, tracking start-up progress and meeting deadlines.
Required Skills and Qualifications:
  • University/College degree in life sciences or related health profession, or equivalent experience with 4+ years in clinical research.
  • Strong knowledge of ICH guidelines, RA, IRB/IEC regulations, and experience with investigator start-up documents is necessary.
  • Advanced English proficiency is also required.
Benefits:

This role offers opportunities for professional growth and development, with a focus on quality and customer service. Strong skills in issue resolution, communication, negotiation, and relationship management are essential.

Others:

Maintaining audit readiness through consistent system compliance is also a key responsibility. Leadership qualities, strategic thinking, resilience, cultural awareness, and a focus on quality and customer service are highly valued.

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